Institutional Review Board (IRB)

Applications and protocols are accepted by ORSP on behalf of the board and reviewed weekly by the IRB chairperson or designee. Protocols requiring review by the full Institutional Review Board must be received a minimum of one month prior to the Board’s meeting date.

• IRB Guidelines
• Guidelines For Letters From Agencies Cooperating With the Research
• Guidelines For Students Conducting Research Involving Human Subjects
• Guidelines For Obtaining Assent From Children Or Minors And Guidelines For Parental Consent
• IRB Amendment / Continuation / Closure Request Form - contact Sherry Alexander for help in filling out this form
• IRB Application - contact Sherry Alexander for help in filling out this form
• IRB Application Instructions
• 2021 Child Assent and Parental Consent Model Instructions
• 2021 Child Assent and Parent Consent Model Form
• 2019 Online Consent Model Instructions
• 2019 Online Consent Model Form
• 2019 Oral Consent Model Instructions
• 2019 Oral Consent Model Form
• 2019 Signed Informed Consent Model Instructions
• 2019 Signed Informed Consent Model Form

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• Code of Federal Regulations 45CFR46
• Human Subject Protections Office for Human Research Protections (OHRP)
• Human Subjects for Behavioral and Social Science Research National Science Foundation (NSF)
• International Compilation of Human Research Standards (2014 edition)
• U.S. Food and Drug Administration
• PRIM&R Public Responsibility in Medicine and Research
• The Belmont Report
• Office of Behavioral and Social Sciences Research (NIH)

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All investigators and key study personnel* must hold a current certificate of completion of the appropriate Collaborative Institutional training Initiative (CITI) Human Subjects in Research training course before conducting human subjects research. This requirement includes individuals added to a protocol via an amendment.

The initial renewal of training in Human Subjects in Research is required every five years. Investigators and key study personnel* must renew their training by taking a shorter refresher course offered by CITI. Subsequent renewals are required every three years.

*key study personnel include all individuals, including students, who enroll research subjects, obtain informed consent or screen potential subjects, and who analyze or report identifiable research data.

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The federal HIPAA Privacy Rule protects the privacy of personal health information. To meet the training requirements of HIPAA and other US statutory/regulatory authorities, FGCU offers an online course in health information privacy and security through the Collaborative Institutional Training Initiative (CITI).

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